NCT04015960

Brief Summary

Despite biologic drugs and improvements of inflammatory arthritis (IA) treatment, many patients with inflammatory arthritis still face increased absenteeism, reduced at-work productivity and report difficulties working and having to give up their jobs. Such professional limitation generates psychological stress and it felt generally as a premature social ageing. "Making-it-Work" is an intervention developed in English speaking Canada, which aims at enabling both patients and employers to intervene early during the course of inflammatory arthritis to reduce possible problems at work, and to prevent sick leave and future work disability in the long term and improve well-being at work. As part of the EVADE (Evaluation of the effectiVeness of an ADaptation of the Making it-Work intervention in a French Environment) project which aims at evaluating the effectiveness of an adaptation of the "Making-it-Work" intervention, to the French environment, the investigators propose :

  1. 1.to identify the problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.
  2. 2.to develop a questionnaire to assess difficulties at work, needs for adaptations and support and motivations to work of patients with inflammatory arthritis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

June 27, 2019

Last Update Submit

June 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Problems faced at work due to IA, patients needs, motivations to continue working and strategies helpful for maintaining employment.

    focus groups and/or individual semi-structured interviews

    baseline

Interventions

qualitative research and patient reported outcome measure (PROm) development

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inflammatory arthritis (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis) with difficulties at work

You may qualify if:

  • Physician diagnosis of IA (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis)
  • Age 18 to 65 years
  • Currently employed
  • Having concerns about their IA at work ("Do you have any concern about your arthritis affecting your ability to work now, or in the next five years?),

You may not qualify if:

  • Sick leave of more than 3 years
  • Health care professionals (clinicians, nurses experts in therapeutic education, occupational physicians), a vocational counsellor, and professionals of the prevention and security at work, professionals from the pension insurance fund and health at work or professionals involved in accommodation of working conditions for disabled workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Lorraine

Nancy, France

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Anne-Christine Rat, MD, PhD

    University of Lorraine

    PRINCIPAL INVESTIGATOR
  • Isabelle Thaon, MD, PhD

    University of Lorraine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 11, 2019

Study Start

October 1, 2019

Primary Completion

July 30, 2020

Study Completion

July 30, 2021

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations